FDA-Device2022-04-27Class II
Merlin 2 PCS MER3700 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
Hazard
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM.
Affected count
401 devices with software
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
Merlin 2 PCS MER3700 programmer Model MER3400 software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2022Don't want to check this manually?
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